Active pharmaceutical ingredient on a solid support,...

Details Active pharmaceutical ingredient on a solid support,... Active pharmaceutical ingredient on a solid support,...

A - Human Necessities

61

K

A61K 9/18 (2006.01) A61K 31/122 (2006.01) A61K 31/397 (2006.01)

Patent

CA 2710125

The present invention discloses a combination preparation comprising an active pharmaceutical ingredient (API) and a pharmaceutically acceptable solid support, wherein said solid support is in a water-insoluble particulate form and comprises a material selected from silicic acid, aluminum hydroxide and titanium hydroxide, wherein said API is a compound having both, at least one hydrophobic structural moiety causing the API to have a low solubility in water or in an aqueous solution, and multiple hydrophilic groups arranged to form multiple intermolecular interactions to said solid support involving polar or ionic or hydrogen bonding, wherein the hydrophilic groups of the API are independently equal or different and comprise at least one of the groups consisting of OH- and halogen-groups; wherein said API is bound to said solid support by adsorption, and wherein a major pro- portion of said API is in the amorphous state. The present invention also discloses a pharmaceutical preparation comprising such a combination preparation as well as a method for producing such a combination preparation.

Cette invention concerne une préparation d'association comprenant un principe actif pharmaceutique (API) et un support solide pharmaceutiquement acceptable, ledit support solide se trouvant sous forme de particules insolubles dans l'eau et comprenant un matériau choisi parmi l'acide silicique, l'hydroxyde d'aluminium et l'hydroxyde de titane, ledit API étant un composé ayant à la fois, au moins une fraction structurelle hydrophobe causant la faible solubilité de l'API dans l'eau ou dans une solution aqueuse, et plusieurs groupes hydrophiles agencés de manière à former plusieurs interactions intermoléculaires avec le support solide impliquant une liaison polaire ou ionique ou hydrogène, lesdits groupes hydrophiles de l'API étant indépendamment équivalents ou différents et comprenant au moins l'un des groupes constitués par OH- et des groupes halogène ; ledit API étant lié au support solide par adsorption, et la majeure partie dudit API se trouvant à l'état amorphe. L'invention concerne également une préparation pharmaceutique comprenant ce type de préparation d'association, ainsi qu'un procédé de production de cette préparation d'association.

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